Acute and Chronic Inflammatory Disease, Lifestyle and Treatment Response

NCT ID: NCT04193020

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2026-01-01

Brief Summary

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Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other.

Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease.

This prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG).

At baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.

Detailed Description

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Conditions

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Uveitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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steroid only group (SG)

Surveillance card

Intervention Type OTHER

Surveillance card and additional examination to find novel markers and better assess the existing ones

combined (steroid and adjuvant drug) group (CG)

Surveillance card

Intervention Type OTHER

Surveillance card and additional examination to find novel markers and better assess the existing ones

bilogic therapy group (BTG)

Surveillance card

Intervention Type OTHER

Surveillance card and additional examination to find novel markers and better assess the existing ones

Interventions

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Surveillance card

Surveillance card and additional examination to find novel markers and better assess the existing ones

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* new diagnosis of uni or bilateral uveitis
* recurrence of the diagnosed previously uni or bilateral uveitis

Exclusion Criteria

* not mentally able to reply the questionnaire
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wrocław University of Science and Technology

OTHER

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Joanna Przeździecka-Dołyk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Misiuk-Hojło, Professor

Role: STUDY_CHAIR

Medical University of Wrocław

Locations

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Department of Ophthalmology

Wroclaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Joanna Przeździecka-Dołyk, PhD

Role: CONTACT

+49605693022

Facility Contacts

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Joanna Przeździecka-Dołyk, PhD

Role: primary

Other Identifiers

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ST-859

Identifier Type: -

Identifier Source: org_study_id

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